MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE X TACTIFLEX SE SW MODULE V3.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-TFM-3.1
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an ablation procedure, it was found that the tactiflex software had not been installed resulting in cancellation of the procedure.After connecting the tactiflex se, an error appeared that the catheter had been reused or used on another patient.The catheter was reconnected, a new study was started, the system was rebooted, and the catheter was exchanged with no resolve.Customer service was called, and the software was checked.It was discovered that the tactiflex software was missing.The procedure was aborted at this time because the software was not available and there was difficult patient anatomy.Once the disk was obtained, and the software was installed the issue resolved.
Additional Manufacturer Narrative
The results of the investigation are undetermined as the device was not returned for analysis.A review of the packaging and verification could not be completed as a batch or sales order number was not provided.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.The cause for the reported tactiflex software not being installed and subsequent delay remains unknown.

• Brand Name: ENSITE X TACTIFLEX SE SW MODULE V3.1
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21322846
• Report Number: 2184149-2025-00025
• Device Sequence Number: 15420309
• Product Code: DQK
• UDI-Device Identifier: 05415067049711
• UDI-Public: 05415067049711
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K242016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ENSITE-TFM-3.1
• Device Catalogue Number: ENSITE-TFM-3.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female